NCT02332967

Brief Summary

The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than those of infants receiving a control formula.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
Last Updated

January 13, 2015

Status Verified

November 1, 2014

Enrollment Period

4.6 years

First QC Date

October 30, 2014

Last Update Submit

January 12, 2015

Conditions

Healthy Newborn Infants

Outcome Measures

Primary Outcomes (2)

  • Stool consistency

    To demonstrate that the infants receiving an infant formula with 40% or 50% of palmitic acid during the first 4 months of life have softer stools than the ones receiving the control formula.

    4 months

  • Baby weight gain

    To demonstrate that the weight gain in babies receiving the experimental formula is the same as with the control formula

    4 months

Secondary Outcomes (8)

  • Baby length and head circumference

    4 months

  • Digestive tolerance using a questionnaire filled in by the mothers

    4 months

  • Gut microbiota using microbiology method

    4 months

  • Fat quantity in the stools

    4 months

  • Baby body composition (DEXA)

    4 months

  • +3 more secondary outcomes

Study Arms (3)

Whey predominant starter formula

ACTIVE COMPARATOR

Whey predominant starter formula

Other: Whey predominant starter formula + 40% palmitic acidOther: Whey predominant starter formula + 50% palmitic acid

Whey predominant starter formula + 40% palmitic acid

EXPERIMENTAL

Whey predominant starter formula + 40% palmitic acid in sn-2 position

Other: Whey predominant starter formula

Whey predominant starter formula + 50% palmitic acid

EXPERIMENTAL

Whey predominant starter formula + 50% palmitic acid in sn-2 position

Other: Whey predominant starter formula

Interventions

Whey predominant starter formulaOTHER

Milk powder product given to babies between 1 week and 4 months

Whey predominant starter formula + 40% palmitic acidWhey predominant starter formula + 50% palmitic acid
Whey predominant starter formula + 40% palmitic acidOTHER

Milk powder product containing 40% of palmitic acid

Whey predominant starter formula
Whey predominant starter formula + 50% palmitic acidOTHER

Milk powder product containing 50% of palmitic acid

Whey predominant starter formula

Eligibility Criteria

Age1 Week - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy newborn infants
  • full term infant (37 - 42 weeks gestation)
  • birth weight between 2.5 and 4.5 kg
  • singleton birth
  • the infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age
  • having obtained his7her legal representative's informed consent

You may not qualify if:

  • congenital illness or malformation that may affect normal growth
  • significant pre-natal and/or post-natal disease
  • hospitalization in the first 14 days of life after the child has left the maternity ward
  • receiving antibiotic treatment at time of enrolment
  • newborn whose parents/caregivers cannot be expected to comply with treatment
  • newborn currently participating in another interventional clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Beghin L, Marchandise X, Lien E, Bricout M, Bernet JP, Lienhardt JF, Jeannerot F, Menet V, Requillart JC, Marx J, De Groot N, Jaeger J, Steenhout P, Turck D. Growth, stool consistency and bone mineral content in healthy term infants fed sn-2-palmitate-enriched starter infant formula: A randomized, double-blind, multicentre clinical trial. Clin Nutr. 2019 Jun;38(3):1023-1030. doi: 10.1016/j.clnu.2018.05.015. Epub 2018 Jun 1.

    PMID: 29903473DERIVED

MeSH Terms

Interventions

Palmitic Acid

Intervention Hierarchy (Ancestors)

Palmitic AcidsFatty AcidsLipids

Study Officials

  • Dominique Turck, Prof

    Gatroenterology and Nutrition, Pediatric dept, CHRU Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

January 7, 2015

Study Start

July 1, 2007

Primary Completion

February 1, 2012

Study Completion

September 1, 2012

Last Updated

January 13, 2015

Record last verified: 2014-11